BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    UPGRADED SPIROMETER ST-90

    K Number: K933511 · Decision Feb 10, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    18
    Registration Numbers
    18
    Same Product Code
    62
    Applicant Total
    17
    Review Days
    210

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    Basic Information

    Device Name
    UPGRADED SPIROMETER ST-90
    K Number
    K933511
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.1890
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Futuremed Div. of Future Impex Corp.
    Date Received
    July 15, 1993
    Decision Date
    February 10, 1994
    Product Code
    BTY
    Advisory Committee
    Anesthesiology
    Review Advisory Committee
    AN
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    BTY Calculator, Predicted Values, Pulmonary Function

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    Other Clearances by Futuremed Div. of Future Impex Corp.

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    K901308 SPIRO ANALYZER MODEL ST 250
    K884972 TRANSCOUTANEOUS ELECTRO-NEURO STIMULATOR
    K871421 MODEL HL-100 PORTABLE DC ELECT. THERAPEUTIC UNIT
    K873817 SPIRO ANALYZER ST-300
    K872044 CARBON ELECTRODE
    K871913 CONDUCTIVITY GEL
    K872045 CONDUCTIVITY GEL
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